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THE PHARMA REVIEW (MARCH - APRIL 2011)

Current Status of Dietary Supplements in India

Ashok K. Maity1, Tulsi Chakrabarti2, Subhash C. Mandal3

Abstract: Dietary supplements (DS) showed an upsurge during last few years throughout the globe including India. It was felt that production and marketing is not properly regulated in India leaving ample scope of compromising the safety of the consumers of DS. A study has been undertaken to find out the status of the dietary supplements in the Indian market and suggest regulatory measures, at least, for manufacturing, labeling, safety and quality aspects so as to safeguard the interest of the common people. The study was conducted in 50 wholesale and 100 retail medicine outlets spread over Malda district in West Bengal between June 2008 and May 2010. Change of life style of the populace via-a-vis high profile marketing through print and electronic media are believed to be the main reason behind such upsurge. A serious trend has been revealed concerning shifting of a drug to Dietary Supplement category made possible due to existing lenient regulation on Dietary Supplements in India. Manufacturing of DS does not require maintaining GMP or GLP and other regulatory requirements favoring it’s low cost of production and more profit. Further less legislation on DS in comparison to drugs helps its easy access to market. Less regulation on production and less vigilance in the market may compromise the safety of the people who will be using such DS. Thus it is high time that some legislation is brought in or PFA Act amended to differentiate a DS clearly from a drug and it is produced properly.
Introduction
A dietary supplement (DS), also known as food supplement or nutritional supplement, is a preparation intended to supplement the diet and provide nutrients, such as vitamins, minerals, fiber, fatty acids, or amino acids, probiotics, that may be missing or may not be consumed in sufficient quantities in a person’s diet. Some countries define dietary supplements as foods, while in others they are defined as drugs or natural health products. Dietary supplements containing vitamins or dietary minerals are included as a category of food in the Codex Alimentarius, a collection of internationally recognized standards, codes of practice, guidelines and other recommendations relating to foods, food production and food safety. These texts have been drawn up by the Codex Alimentarius Commission, an organization that is sponsored by the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO). Enactment of Dietary Supplement and Health Education Act 1994 (DSHEA) by US FDA has clearly demarcated a line between Drugs and Food resulting emergence of Dietary supplements, in the form of tablets, capsules, liquids, powders, drops etc.1. It has further imposed stringent regulation on DS by enactment of Food and Drug Administration Modernization Act in the year of 1997 2. Vitamin-mineral markets are under pressure due to tightening of regulatory controls and competition from functional foods and drinks. Despite this, the global market is expected to grow at a CAGR of 4.5% approaching $30bn in 2015. During last few years Indian Nutraceuticals market showed an upward trend as per a survey conducted by Cygnus research 3. The global market of DS is estimated around $ 80 billion with a growth rate of 10%. But in the emerging market like India, the growth is estimated to be around 25%. Currently, the domestic market for nutraceutical is around Rs. 4,400 crore, which is just 0.9% of the total global business in the category, which is expected to be Rs. 9500 crores by 2015. DS with or without calorie producing substances like protein, fat, etc. are marketed in the form of tablet, capsule, liquids, etc and has no visual differences from Drugs / Medicines as conceived and understood by general public. They are sold only from medicine shops. The product presentation, labeling are similar to drugs and hence it is very difficult for consumer, traders, doctors or an even a drug officer to differentiate a DS from a drug.

 

 

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